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Androgen Biosynthesis Inhibitor
Abiraterone + Prednisone/Olaparib for Prostate Cancer
Phase 2
Waitlist Available
Led By Maha Hussain, MD, FACP, FASCO
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG status of 0-2 (Appendix A: Performance Status Criteria)
Serum testosterone < 50 ng/dL. Patients must continue primary ADT with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for men with metastatic castration resistant prostate cancer. It is a 1:1:1 randomized open-label multicenter phase II study, which means that patients will be randomly assigned to one of three different treatment groups. The study will take place at multiple centers, and patients will be observed over the course of the trial.
Who is the study for?
Men with metastatic castration-resistant prostate cancer and specific DNA repair defects (like ATM, BRCA mutations) can join. They must have a life expectancy of at least 6 months, be able to take oral meds, agree to use contraception for 3+ months after the trial, and not have had certain treatments like CYP17 inhibitors or chemotherapy for resistant disease. No major surgery or uncontrolled medical issues within 14 days before joining.Check my eligibility
What is being tested?
The study is testing three approaches: Abiraterone/Prednisone alone, Olaparib alone, or both combined in men with advanced prostate cancer who have genetic changes affecting DNA repair. It's an open-label phase II trial where patients are randomly assigned to one of the treatment arms.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, low blood counts that could increase infection risk; liver problems; shortness of breath; rash; joint pain; high blood pressure and other heart-related issues. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.
Select...
I stopped taking hormone therapy for cancer 4 weeks ago and my PSA levels haven't dropped.
Select...
I have been diagnosed with prostate adenocarcinoma, not small-cell carcinoma.
Select...
I can swallow pills without needing to break them down.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Progression Free Survival (PFS)
Secondary outcome measures
Incidence of Adverse Events
Measurable disease response rate by RECIST
PSA response rate
+6 moreTrial Design
4Treatment groups
Active Control
Group I: Arm I: Abiraterone + PrednisoneActive Control2 Interventions
Abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily, days 1-28 in 28 day cycles.
Group II: Arm II: OlaparibActive Control1 Intervention
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
Group III: Arm III: Abiraterone + Prednisone + OlaparibActive Control3 Interventions
Abiraterone 1000 mg orally once daily, prednisone 5 mg orally twice daily, olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
Group IV: OlaparibActive Control1 Intervention
Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,591 Previous Clinical Trials
917,582 Total Patients Enrolled
20 Trials studying Prostate Cancer
2,959 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,274 Previous Clinical Trials
288,613,351 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,449 Total Patients Enrolled
563 Trials studying Prostate Cancer
507,336 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stopped taking all strong medications that affect liver enzymes.I am allergic to medications similar to olaparib or abiraterone.I am HIV-positive and on antiretroviral therapy, which may interact with the treatment.I have had a seizure or multiple seizures in the past 2 years.I have a specific DNA repair defect and severe disease in my organs or bones needing quick treatment.I can take care of myself and am up and about more than half of the day.I can take a daily Multi-Vitamin, calcium, and Vitamin D but must stop all other supplements and hormonal treatments before starting the trial.I have taken ketoconazole for prostate cancer but not other CYP17 or PARP inhibitors.I haven't taken itraconazole, ketoconazole, or fluconazole in the last 3 weeks.I do not have a history of pituitary or adrenal problems, nor do I have active hepatitis or chronic liver disease.I have long-term blood-related issues, including bone marrow problems.I stopped taking certain medications like phenytoin and St John's Wort 3 weeks ago.I stopped taking phenobarbital 5 weeks ago.I agree to a biopsy to check for DNA repair defects in my cancer.I agree to use contraception during and for 3 months after the study.I stopped taking hormone therapy for cancer 4 weeks ago and my PSA levels haven't dropped.My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.I have recovered from any surgery or radiation therapy side effects.I've had chemotherapy for hormone-resistant cancer, but stopped at least 4 weeks ago.I have moderate to severe liver problems.I have been diagnosed with prostate adenocarcinoma, not small-cell carcinoma.I have active brain metastases.I have not had major surgery in the last 2 weeks or have fully recovered from it.I have a serious health condition that is not under control.I have not had a blood transfusion in the last 30 days.I do not have active Hepatitis B or C.I stopped taking certain medications like ritonavir a week ago.My organs are functioning well, as tested within the last 14 days.I have a history of serious heart problems.I haven't taken any forbidden medications in the last week.I am willing and able to follow the study's treatment plan and attend all visits.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have another active cancer besides non-dangerous skin cancer or superficial bladder cancer.I am not planning to undergo chemotherapy, surgery, or radiation while on the trial treatment.I can swallow pills without needing to break them down.I have lasting side effects from cancer treatment, but not hair loss.I have had a bone marrow transplant from another person.You have advanced prostate cancer that is getting worse according to specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I: Abiraterone + Prednisone
- Group 2: Arm II: Olaparib
- Group 3: Arm III: Abiraterone + Prednisone + Olaparib
- Group 4: Olaparib
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What diseases can be treated by the combination of Abiraterone and Prednisone in Arm I?
"Arm I: Abiraterone + Prednisone is traditionally indicated for ulcerative colitis, however it can also be utilized to treat illnesses such as varicella-zoster virus acute retinal necrosis and brain iritis."
Answered by AI
How many medical centers are conducting this experiment?
"Patients have the option to enroll in 15 different sites across the United States. This includes Chapel Hill, Charlottesville and Chicago as well as 12 other locations. To reduce travel demands, it is recommended that you select a location nearest your residence."
Answered by AI
What is the current sample size of this experimental research?
"As of August 28th, 2023, this trial is no longer recruiting. Originally posted on December 1st 2017, it has since been replaced by a selection of 1263 clinical trials for prostate cancer and 480 studies specifically testing Arm I: Abiraterone + Prednisone."
Answered by AI
Is an opportunity still available to participate in this experiment?
"This research is not currently accepting patients. Initially posted on 12th January 2017, and last modified on the 28th August 2023, there are a plethora of other clinical trials for prostate cancer (1263) and Arm I: Abiraterone + Prednisone (480)."
Answered by AI
Has there been any research conducted on the combination of Abiraterone and Prednisone in Arm I?
"Presently, Arm I: Abiraterone + Prednisone is being studied in 480 clinical trials. Of those, 109 are Phase 3 studies. Despite the majority of these experiments taking place in Rochester, Minnesota there are 24329 different sites that have been enrolled for this specific therapy."
Answered by AI
How can patients be assured of their safety when taking Arm I: Abiraterone + Prednisone?
"Arm I: Abiraterone + Prednisone's safety is assessed to be a 2 on the scale of 1 to 3 due to its Phase 2 status. While there are some data that suggest it is safe, no evidence has been provided as yet regarding its efficacy."
Answered by AI
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